Today, Lonza is a global leader in life sciences operating across three continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that’s the kind of work we want to be part of.
Lonza is establishing a strategic biomanufacturing base in China using GE Healthcare Solutions. With the new facility, Lonza is responding to growing demand for a high-quality CDMO in the Chinese market.
As Filling Engineer, you will provide front line expert support for all process-specific issues to production within one or more production steps, to ensure execution of processes on-time, continuously improving in quality and efficiency, performed in compliance to cGMPs, SOPs, SHE and applicable guidelines
- Shop floor support:
- Provide front line support to manufacturing, working with the operator, focusing on manufacturing process and executing each batch safely, on time, in compliance with the batch instructions and quality requirements.
- Technical improvement execution:
- Execute process improvements, scale-up.
- Drive process related trouble shooting/investigations
- Ensure that process technical batches generate sufficient process knowledge by thoroughly testing critical variables.
- Deviation, complaint handling:
- Lead product and process related investigations and deviations including complaints actions
- Use scientific and statistical knowledge to analyze data to provide process understanding, and to identify root causes of product and process failures.
- Assign, lead and execute actions and CAPAs and changes in Trackwise.
- Audit support:
- Maintain their processes at Inspection readiness level and to provide the necessary support in any internal or external audit
- FAT,SAT,I/O/PQ :
- Contribute to FAT/SAT,I/O/PQ of equipment.
- Perform review of batch records & ESP
- Validation and technical transfers - execution and review of protocol/report:
- Support the execution of process validations, re-validations and short-term improvement projects, liaising with all the relevant parties at shop floor to ensure accurate execution.
- Review and assure that validation protocols and report are technically correct. Ensure protocols are executed as intended
- Subject Matter Expert for manufacturing processes incl. creating and maintaining SOP’s & risk assessments
- Provide training for assigned new processes and products
- Creation / maintenance of process recipes
- Other tasks and duties as assigned
- College degree and above， in Engineering, Pharmaceutical Technology, Chemistry, Pharmacy or equivalent scientific degree / equivalent experience.
- Practical experience in process support role on the shop floor of GMP manufacturing and/or QA/QC.
- Proven process understanding (Pharma, GMP, Regulatory aspects) & proven process understanding in Sterile Manufacturing (Pharma, regulatory aspects)
- Familiarity with GMP requirements, quality procedures and SOP execution
- Good communication skills and interaction with a variety of interfaces within the organization and on the shopfloor
- Strong team orientation, Structured and proactive working attitude
- Self-driven and result-oriented.
- Proven IT knowledge, knowledge in SAP or MES is an asset;
Every day, Lonza’s products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically.
People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference.